Staple cartridge comprising a staple driver arrangement

ABSTRACT

A staple cartridge for use with a stapling device that has an actuator that is selectively actuatable in an axial direction and an anvil portion that is selectively movable between open and closed positions is disclosed. Various embodiments of the present invention include a cartridge body that movably supports first and second staple drivers. The staple drivers each support a staple thereon and serve to drive the staples into forming contact with the anvil upon actuation by the actuator. The various embodiments of the present invention enable the final formed heights of the staples to be varied so as to apply various clamping forces and pressures to soft tissue captured within the staples. In at least one embodiment, the staples can include crowns formed thereon which can be utilized to adjust or control the clamping force and/or pressure applied by the staples.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 13/965,877, entitledSTAPLE CARTRIDGE COMPRISING A STAPLE DRIVER ARRANGEMENT, filed Aug. 13,2013, which issued on Feb. 7, 2017 as U.S. Pat. No. 9,561,032, which isa continuation application claiming priority under 35 U.S.C. § 120 toU.S. patent application Ser. No. 13/072,923, entitled STAPLE CARTRIDGESFOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS, filed Mar.28, 2011, which issued on Oct. 29, 2013 as U.S. Pat. No. 8,567,656,which is a continuation application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 12/038,939, entitled STAPLECARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS,filed Feb. 28, 2008, which issued on May 3, 2011 as U.S. Pat. No.7,934,630, which is a continuation-in-part application claiming priorityunder 35 U.S.C. § 120 to U.S. patent application Ser. No. 11/216,562,entitled STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS, filed on Aug. 31, 2005, which issued on Mar. 2, 2010 asU.S. Pat. No. 7,669,746; U.S. patent application Ser. No. 12/038,939,entitled STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS, filed Feb. 28, 2008, which issued on May 3, 2011 as U.S.Pat. No. 7,934,630 is a continuation-in-part application claimingpriority under 35 U.S.C. § 120 to U.S. patent application Ser. No.11/541,374, entitled SURGICAL STAPLES HAVING DISSOLVABLE, BIOABSORBABLEOR BIOFRAGMENTABLE PORTIONS AND STAPLING INSTRUMENTS FOR DEPLOYING THESAME, filed on Sep. 29, 2006, which issued on Feb. 5, 2013 as U.S. Pat.No. 8,365,976; and U.S. patent application Ser. No. 12/038,939, entitledSTAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLEHEIGHTS, filed Feb. 28, 2008, which issued on May 3, 2011 as U.S. Pat.No. 7,934,630 is a continuation-in-part application claiming priorityunder 35 U.S.C. § 120 to U.S. patent application Ser. No. 11/824,251,entitled SURGICAL STAPLE HAVING A SLIDABLE CROWN, filed on Jun. 29,2007, which issued on Mar. 31, 2015 as U.S. Pat. No. 8,991,676, theentire disclosures of which are hereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates in general to stapling instruments thatare capable of applying lines of staples and, more particularly, toimprovements relating to staple cartridges for use with surgicalstapling instruments that are capable of applying lines of stapleshaving differing formed staple heights to tissue while simultaneouslycutting the tissue.

BACKGROUND OF THE INVENTION

Surgical staplers have been used in the prior art to simultaneously makea longitudinal incision in tissue and apply lines of staples on opposingsides of the incision. Such instruments commonly include a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges that, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLINGINSTRUMENT HAVING SEPARATE AND DISTINCT CLOSING AND FIRING SYSTEMS,which issued on Feb. 21, 2006, the entire disclosure of which is herebyincorporated by reference herein. In use, a clinician is able to closethe jaw members of the stapler upon tissue to position the jaw membersprior to firing. Once the clinician has determined that the jaw membersare properly gripping tissue, the clinician can then fire the surgicalstapler, thereby severing and stapling the tissue. The simultaneoussevering and stapling avoids complications that may arise whenperforming such actions sequentially with different surgical tools thatrespectively only sever or staple.

Whenever a transection of tissue is across an area of varied tissuecomposition, it would be advantageous for the staples that are closestto the cut line to have one formed height that is less than the formedheight of those staples that are farthest from the cut line. Inpractice, the rows of inside staples serve to provide a hemostaticbarrier, while the outside rows of staples with larger formed heightsprovide a cinching effect where the tissue transitions from the tightlycompressed hemostatic section to the non-compressed adjacent section. Inother applications, it may be useful for the staples in a single line ofstaples to have differing formed heights. U.S. Pat. Nos. 4,941,623 and5,027,834 disclose surgical stapler and cartridge arrangements thatemploy staples that have different prong lengths to ultimately achievelines of staples that have differing formed heights. Likewise, WO2003/094747 discloses a surgical stapler and cartridge that has six rowsof staples wherein the outer two rows of staples comprise staples thatare larger than the staples employed in the inner two rows and middlerows of staples. Although the above-disclosed staples and staplecartridges may be suitable for their intended purpose, what is needed isan improvement over the foregoing.

BRIEF SUMMARY OF THE INVENTION

In at least one form of the invention, a staple cartridge can beconfigured to deploy staples in rows, where the staples in a first rowcan be deformed to a different height than the staples in a second row.In at least one embodiment, the staple cartridge can include a firstdriver for deploying a staple in the first row a first distance and asecond driver for deploying a staple in the second row a seconddistance, wherein the first distance can differ from the seconddistance. Owing to the different distances in which the staples can bedeployed, the staples can be deformed to various heights such that thestaples within the first row can apply different clamping forces to softtissue captured therein as compared to the staples within the secondrow.

In at least one form of the invention, a staple cartridge can includeother various features which can deform staples to different heightsand/or create different clamping forces within the staples. In variousembodiments, the staples in a first row of a staple cartridge caninclude a crown, a tissue-contacting surface on the crown, and adeformable member extending from the crown, where a first distance canbe defined between the tissue-contacting surface and a bottom surface ofthe crown. The staples in a second row of the staple cartridge can alsoinclude a crown, a tissue-contacting surface on the crown, and adeformable member, where a second distance can be defined between thetissue-contacting surface and a bottom surface of the crown. In at leastone such embodiment, the first distance can differ from the seconddistance such that the first staples can apply a first force to tissuecaptured therein and the second staples can apply a second force, wherethe first force can differ from the second force.

In at least one form of the invention, the crowns of various staples caninclude tissue-contacting surfaces which can comprise contact areasacross which soft tissue can be supported by the crowns. In variousembodiments, such tissue-contacting surfaces can reduce the clampingpressure applied by the staples. In at least one embodiment, stapleswhich are deformed to shorter heights and/or apply a larger clampingforce can include larger tissue-contacting surfaces as compared to thetissue-contacting surfaces of staples which are deformed to tallerheights and/or apply a smaller clamping force so as to substantiallyequalize, or at least control, the pressures applied by the staples tosoft tissue captured within the staples, for example. As a result,embodiments are envisioned in which the size of the tissue-contactingarea and/or the anticipated deformed staple height can be selected toprovide a larger and/or smaller clamping pressure to a particular areaof the treated tissue.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 depicts a partially cut away side elevation view of a surgicalstapling and severing instrument in an open position.

FIG. 2 depicts a cross-sectional side elevation detail view along theline 2-2 of FIG. 1 of an end effector of the surgical stapling andsevering instrument.

FIG. 3 depicts an enlarged side elevation view of the firing bar of thesurgical stapling and severing instrument of FIG. 2.

FIG. 4 depicts an enlarged front view of the firing bar of the surgicalstapling and severing instrument of FIG. 2.

FIG. 5 depicts a cross-sectional side elevation detail view of analternative end effector for the surgical stapling and severinginstrument of FIG. 1, incorporating a firing bar that lacks a middle pinfor preventing pinching of the end effector.

FIG. 6 depicts a side elevational view of a handle portion of a proximalend of the surgical stapling and severing instrument of FIG. 1 with aleft side removed to expose interior parts in an unclamped, unfired(“start”) position.

FIG. 7 depicts a perspective, exploded view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1.

FIG. 8 depicts a side elevational view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1with the left side removed to expose interior parts in the closed(“clamped”) position.

FIG. 9 depicts a side elevational view of the handle portion of proximalend of surgical stapling and severing instrument of FIG. 1 with the leftside removed to expose interior parts in the stapled and severed(“fired”) position.

FIG. 10 depicts a plan view of a staple cartridge installed in an endeffector of an embodiment of the present invention.

FIG. 11 is an enlarged plan view of a portion of a staple cartridgeembodiment of the present invention.

FIG. 12 is a side view of a staple that may be employed with variousembodiments of the present invention.

FIG. 13 is a front elevational view of one inside double driver of oneembodiment of the present invention supporting two staples thereon.

FIG. 14 is a top view of the inside double driver and staples of FIG.13.

FIG. 14A is an elevational view of the inside double driver of FIG. 13within a portion of a staple cartridge mounted in the end effector andalso illustrating a corresponding portion of the anvil when in a closedposition.

FIG. 15 is a right side elevational view of the inside double driver andstaples of FIGS. 13 and 14.

FIG. 15A is another side elevational view of the inside double driver ofFIG. 15 wherein corresponding portions of the cartridge tray and anvilare illustrated in broken lines to depict the relationshipstherebetween.

FIG. 16 is a front elevational view of one outside single driver of oneembodiment of the present invention supporting a staple thereon.

FIG. 16A is another front view of the outside single driver of FIG. 16with portions of the cartridge tray and anvil shown to illustrate therelationships therebetween.

FIG. 17 is a top view of the outside single driver and staple of FIG.16.

FIG. 18 is an isometric exploded view of the implement portion of thesurgical stapling and severing instrument of FIG. 1.

FIG. 19 is a section view taken along line 19-19 of FIG. 10 showing thecross-sectional relationship between the firing bar, elongate channel,wedge sled, staple drivers, staples and staple cartridge.

FIG. 19A is another cross-sectional view of an end effector embodimentof the present invention showing the cross-sectional relationshipbetween the firing bar, elongate channel, wedge sled, staple drivers,staples, staple cartridge and anvil.

FIG. 20 is a perspective view of one wedge sled embodiment of thepresent invention.

FIG. 21 is a side elevational view of an inside sled cam of the wedgesled depicted in FIG. 20.

FIG. 22 is a side elevational view of an outside sled cam of the wedgesled depicted in FIG. 20.

FIG. 23 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position with the cartridge largely removed exposing asingle staple driver and a double staple driver as exemplary and thewedge sled in its start position against a middle pin of the firing bar.

FIG. 24 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position exposing the staple cartridge and cuttingedge of the firing bar.

FIG. 25 is an isometric view of the distal end of the surgical staplingand severing instrument of FIG. 1 with the anvil in the up or openposition with the staple cartridge completely removed and a portion ofan elongate channel removed to expose a lowermost pin of the firing bar.

FIG. 26 is a side elevation view in section showing a mechanicalrelationship between the anvil, elongate channel, and staple cartridgein the closed position of the surgical stapling and severing instrumentof FIG. 1, the section generally taken along lines 26-26 of FIG. 24 toexpose wedge sled, staple drivers and staples but also depicting thefiring bar along the longitudinal centerline.

FIG. 27 is a cross-sectional view of a portion of one embodiment of astaple cartridge of the present invention wherein an outside cam of awedge is adjacent to an outside single driver.

FIG. 28 is a cross-sectional view of a portion of one embodiment of astaple cartridge of the present invention wherein an outside cam of awedge sled is engaging three outside single drivers.

FIG. 29 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of one embodiment of the present invention.

FIG. 30 depicts a staple formed by one inside driver embodiment of thepresent invention.

FIG. 31 depicts another staple formed by one outside driver embodimentof the present invention.

FIG. 32 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 33 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 34 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 35 is a side elevation section view of the surgical stapling andsevering instrument of FIG. 1 taken along the longitudinal centerline ofthe end effector in a partially closed but unclamped position grippingtissue.

FIG. 36 depicts a partially cut away side elevational view of thesurgical stapling and severing instrument of FIG. 1 in the closed orclamped position.

FIG. 37 depicts a side elevation view of the surgical stapling andsevering instrument of FIG. 1 in the closed or clamped position withtissue properly compressed.

FIG. 38 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a partially firedposition.

FIG. 39 depicts a partially cut away side elevation view of the surgicalstapling and severing instrument of FIG. 1 in a partially firedposition.

FIG. 40 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a fully firedposition.

FIG. 41 is a partially cut-away side elevational view of the surgicalstapling and severing instrument of FIG. 1 in a full fired position.

FIG. 42 is an elevation view of a surgical staple for use with asurgical stapling and severing instrument of one embodiment of thepresent invention.

FIG. 43 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of one embodiment of the present invention.

FIG. 44 is a cross-sectional view of a staple cartridge for use with asurgical stapling and severing instrument of one embodiment of thepresent invention utilizing staples having different leg lengths.

FIG. 45 is a cross-sectional view of another staple cartridge for usewith a surgical stapling and severing instrument of one embodiment ofthe present invention utilizing staples having different leg lengths.

FIG. 46 is a cross-sectional view of a staple cartridge for use with asurgical stapling and severing instrument of one embodiment of thepresent invention utilizing staples having substantially the samelength.

FIG. 47 is a cross-sectional view of another staple cartridge for usewith a surgical stapling and severing instrument of one embodiment ofthe present invention utilizing staples having substantially the samelength.

FIG. 48 is a diagrammic representation of staples having differentdeformed heights for securing transected tissue.

FIG. 49 is an elevation view of a surgical staple including twoconnected fastener portions for use with a surgical stapling andsevering instrument of one embodiment of the present invention.

FIG. 50 is a perspective view of two unconnected fastener portions of asurgical staple for use with a surgical stapling and severing instrumentof one embodiment of the present invention.

FIG. 51 is a perspective view of the fastener portions of FIG. 50 aftera crown has been overmolded thereon to connect the fastener portions toform the surgical staple.

FIG. 52 is a perspective view of the surgical staple of FIG. 51 afterthe fastener portions have been deformed.

FIG. 53 is a perspective view of the surgical staple of FIG. 51 after atleast a portion of the crown has dissolved to separate the fastenerportions.

FIG. 54 is a perspective view of the surgical staple of FIG. 51 afterthe crown has completely dissolved.

FIG. 55 is an elevation view of a surgical staple having dissolvableportions for use with a surgical stapling and severing instrument of oneembodiment of the present invention.

FIG. 56A is an elevation view of a surgical staple having dissolvableportions for use with a surgical stapling and severing instrument of oneembodiment of the present invention.

FIG. 56B is an elevation view of an alternative embodiment to FIG. 56A.

FIG. 57 is an elevation view of a surgical staple having a slidablecrown in accordance with one embodiment of the present invention.

FIG. 58 is an elevation view of another surgical staple having aslidable crown in accordance with one embodiment of the presentinvention.

FIG. 59 is an elevation view of another surgical staple having aslidable crown in accordance with one embodiment of the presentinvention.

FIG. 60 is a bottom view of the surgical staple of FIG. 57.

FIG. 61 is a bottom view of the surgical staple of FIG. 58.

FIG. 62 is a bottom view of the surgical staple of FIG. 59.

FIG. 63 is a top view of the surgical staple of FIG. 57.

FIG. 64 is a top view of the surgical staple of FIG. 58.

FIG. 65 is a top view of the surgical staple of FIG. 59.

FIG. 66 is a perspective cross-sectional view of a non-deployed surgicalstaple of FIG. 57 positioned within a staple cartridge in accordancewith one embodiment of the present invention.

FIG. 67 is a perspective cross-sectional view of the staple of FIG. 66in a partially deployed position from the staple cartridge.

FIG. 68 is a perspective view of the staple of FIG. 66 in a fullydeployed position from the staple cartridge.

FIG. 69 is a perspective cross-sectional view of the staple of FIG. 66in a fully deployed position.

FIG. 70 is an elevation view of a surgical staple having a slidablecrown in accordance with one embodiment of the present invention.

FIG. 71 is an elevation view of the slidable crown of FIG. 70 movedrelative to the deformable members of the surgical staple.

FIG. 72 is an elevation view of the staple of FIG. 70 deformed to afirst height.

FIG. 73 is an elevation view of the staple of FIG. 70 deformed to asecond height.

FIG. 74 is a partial plan view of a staple cartridge in accordance withone embodiment of the present invention.

FIG. 75 is a detail view of a staple cavity of the staple cartridge ofFIG. 74.

FIG. 76 is a cross-sectional view of the staple cartridge of FIG. 74taken along line 76-76 in FIG. 74.

FIG. 77 is an elevation view of a surgical staple including a crownhaving a first crown height in accordance with one embodiment of thepresent invention.

FIG. 78 is an elevation view of a surgical staple including a crownhaving a second crown height which is larger than the first crown heightof the staple of FIG. 77 in accordance with one embodiment of thepresent invention.

FIG. 79 is an elevation view of a surgical staple including a crownhaving a third crown height which is larger than the second crown heightof the staple of FIG. 78 in accordance with one embodiment of thepresent invention.

FIG. 80 is a diagrammatic representation of rings of staples installedusing a surgical stapling and severing instrument of one embodiment ofthe present invention.

FIG. 81 is a perspective view of first and second deformable membershaving an expandable coating formed thereon in accordance with oneembodiment of the present invention.

FIG. 82 is a top view of the deformable members of FIG. 81.

FIG. 83 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the first and second deformable members of FIG.81 in accordance with one embodiment of the present invention.

FIG. 84 is a perspective view of the staple of FIG. 83 in a deformedconfiguration.

FIG. 85 is a perspective view of the staple of FIG. 83 after at least aportion of the dissolvable material has dissolved and the expandablematerial has expanded.

FIG. 86 is a top view of the staple of FIG. 83 illustrating theexpandable coating in an expanded form.

FIG. 87 is a perspective view of the staple of FIG. 83 after thedissolvable material and the expandable material has completelydissolved.

FIG. 88 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto deformable members in accordance with oneembodiment of the present invention.

FIG. 89 is a perspective view of the staple of FIG. 88 in a deformedshape.

FIG. 90 is a perspective view of the staple of FIG. 88 wherein a portionof the dissolvable material has been dissolved and the first and seconddeformable members have moved relative to one another.

FIG. 91 is a perspective view of the staple of FIG. 88 after thedissolvable or bioabsorbable material has completely dissolved.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the Drawings, wherein like numerals denote like componentsthroughout the several views, FIGS. 1 and 2 depict one embodiment of asurgical stapling and severing instrument 10 that is capable ofpracticing the unique benefits of the present invention. As the presentDetailed Description proceeds, the reader will appreciate, however, thatthe unique and novel aspects of the present invention may beadvantageously employed in connection with a variety of other staplersand stapler instruments without departing from the spirit and scope ofthe present invention. Accordingly, the scope of protection afforded tothe various embodiments of the present invention should not be limitedto use only with the specific type of surgical stapling and severinginstruments described herein.

As can be seen in FIGS. 1 and 2, the surgical stapling and severinginstrument 10 incorporates an end effector 12 having an actuator orE-beam firing mechanism (“firing bar”) 14 that advantageously controlsthe spacing of the end effector 12. In particular, an elongate channel16 and a pivotally translatable anvil 18 are maintained at a spacingthat assures effective stapling and severing. The problems are avoidedassociated with varying amounts of tissue being captured in the endeffector 12.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handle of an instrument.Thus, the end effector 12 is distal with respect to the more proximalhandle portion 20. It will be further appreciated that for convenienceand clarity, spatial terms such as “vertical” and “horizontal” are usedherein with respect to the drawings. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

The surgical and stapling and severing instrument 10 includes a handleportion 20 that is connected to an implement portion 22, the latterfurther comprising a shaft 23 distally terminating in the end effector12. The handle portion 20 includes a pistol grip 24 toward which aclosure trigger 26 is pivotally drawn by the clinician to causeclamping, or closing, of the anvil 18 toward the elongate channel 16 ofthe end effector 12. A firing trigger 28 is farther outboard of theclosure trigger 26 and is pivotally drawn by the clinician to cause thestapling and severing of clamped tissue in the end effector 12.

In practice, closure trigger 26 is actuated first. Once the clinician issatisfied with the positioning of the end effector 12, the clinician maydraw back the closure trigger 26 to its fully closed, locked positionproximate to the pistol grip 24. Then, the firing trigger 28 isactuated. The firing trigger 28 springedly returns when the clinicianremoves pressure. A release button 30 when depressed on the proximal endof the handle portion 20 releases any locked closure trigger 26.

A closure sleeve 32 encloses a frame 34, which in turn encloses a firingdrive member 36 that is positioned by the firing trigger 28. The frame34 connects the handle portion 20 to the end effector 12. With theclosure sleeve 32 withdrawn proximally by the closure trigger 26 asdepicted, the anvil 18 springedly opens, pivoting away from the elongatechannel 16 and translating proximally with the closure sleeve 32. Theelongate channel 16 receives a staple cartridge 37.

With particular reference to FIGS. 2-4, the firing bar 14 includes threevertically spaced pins that control the spacing of the end effector 12during firing. In particular, an upper pin 38 is staged to enter ananvil pocket 40 near the pivot between the anvil 18 and elongate channel16. When fired with the anvil 18 closed, the upper pin 38 advancesdistally within a longitudinal anvil slot 42 extending distally throughanvil 18. Any minor upward deflection in the anvil 18 is overcome by adownward force imparted by the upper pin 38. Firing bar 14 also includesa lowermost pin, or firing bar cap, 44 that upwardly engages a channelslot 45 in the elongate channel 16, thereby cooperating with the upperpin 38 to draw the anvil 18 and the elongate channel 16 slightly closertogether in the event of excess tissue clamped therebetween. The firingbar 14 advantageously includes a middle pin 46 that passes through afiring drive slot 47 formed in a lower surface of the cartridge 300 andan upward surface of the elongate channel 16, thereby driving thestaples therein as described below. The middle pin 46, by slidingagainst the elongate channel 16, advantageously resists any tendency forthe end effector 12 to be pinched shut at its distal end. To illustratean advantage of the middle pin 46, FIG. 5 depicts an alternative endeffector 12′ that lacks a middle pin on a firing bar 14′. In thisdepiction, the end effector 12′ is allowed to pinch shut at its distalend, which tends to impair desired staple formation.

Returning to FIGS. 2-4, a distally presented cutting edge 48 between theupper and middle pins 38, 46 on the firing bar 14 traverses through aproximally presented, vertical slot 49 in the cartridge 37 to severclamped tissue. The affirmative positioning of the firing bar 14 withregard to the elongate channel 16 and anvil 18 assure that an effectivecut is performed. The affirmative vertical spacing provided by theE-Beam firing bar 14 is suitable for the limited size available forendoscopic devices. Moreover, the E-Beam firing bar 14 enablesfabrication of an anvil 15 with a camber imparting a vertical deflectionat its distal end, similar to the position depicted in FIG. 5. Thiscambered anvil 15 advantageously assists in achieving the desired gap inthe end effector 12 even with an anvil 15 having a reduced thickness,which may be more suited to the size limitations of an endoscopicdevice.

With reference to FIGS. 6-9, the handle portion 20 is comprised of firstand second base sections 50 and 52, which are molded from a polymericmaterial such as a glass-filled polycarbonate. The first base section 50is provided with a plurality of cylindrically-shaped pins 54. The secondbase section 52 includes a plurality of extending members 56, eachhaving a hexagonal-shaped opening 58. The cylindrically-shaped pins 54are received within the hexagonal-shaped openings 58 and arefrictionally held therein for maintaining the first and second basesections 50 and 52 in assembly.

A rotating knob 60 has a bore 62 extending completely through it forengaging and rotating the implement portion 22 about its longitudinalaxis. The rotating knob 60 includes an inwardly protruding boss 64extending along at least a portion of the bore 62. The protruding boss64 is received within a longitudinal slot 66 formed at a proximalportion of the closure sleeve 32 such that rotation of the rotating knob60 effects rotation of the closure sleeve 32. It will be appreciatedthat the boss 64 further extends through frame 34 and into contact witha portion of the firing drive member 36 to effect their rotation aswell. Thus, the end effector 12 (not shown in FIGS. 6-9) rotates withthe rotating knob 60.

A proximal end 68 of the frame 34 passes proximally through the rotatingknob 60 and is provided with a circumferential notch 70 that is engagedby opposing channel securement members 72 extending respectively fromthe base sections 50 and 52. Only the channel securement member 72 ofthe second base section 52 is shown. The channel securement members 72,extending from the base sections 50, 52 serve to secure the frame 34 tothe handle portion 20 such that the frame 34 does not movelongitudinally relative to the handle portion 20. The closure trigger 26has a handle section 74, a gear segment section 76, and an intermediatesection 78. A bore 80 extends through the intermediate section 78. Acylindrical support member 82 extending from the second base section 52passes through the bore 80 for pivotably mounting the closure trigger 26on the handle portion 20. A second cylindrical support member 83extending from the second base section 52 passes through a bore 81 offiring trigger 28 for pivotally mounting on the handle portion 20. Ahexagonal opening 84 is provided in the cylindrical support member 83for receiving a securement pin (not shown) extending from the first basesection 50.

A closure yoke 86 is housed within the handle portion 20 forreciprocating movement therein and serves to transfer motion from theclosure trigger 26 to the closure sleeve 32. Support members 88extending from the second base section 52 and securement member 72,which extends through a recess 89 in the yoke 86, support the yoke 86within the handle portion 20.

A proximal end 90 of the closure sleeve 32 is provided with a flange 92that is snap-fitted into a receiving recess 94 formed in a distal end 96of the yoke 86. A proximal end 98 of the yoke 86 has a gear rack 100that is engaged by the gear segment section 76 of the closure trigger26. When the closure trigger 26 is moved toward the pistol grip 24 ofthe handle portion 20, the yoke 86 and, hence, the closure sleeve 32move distally, compressing a spring 102 that biases the yoke 86proximally. Distal movement of the closure sleeve 32 effects pivotaltranslation movement of the anvil 18 distally and toward the elongatechannel 16 of the end effector 12 and proximal movement effects closing,as discussed below.

The closure trigger 26 is forward biased to an open position by a frontsurface 130 interacting with an engaging surface 128 of the firingtrigger 28. Clamp first hook 104 that pivots top to rear in the handleportion 20 about a pin 106 restrains movement of the firing trigger 28toward the pistol grip 24 until the closure trigger 26 is clamped to itsclosed position. Hook 104 restrains firing trigger 28 motion by engaginga lockout pin 107 in firing trigger 28. The hook 104 is also in contactwith the closure trigger 26. In particular, a forward projection 108 ofthe hook 104 engages a member 110 on the intermediate section 78 of theclosure trigger 26, the member 100 being outward of the bore 80 towardthe handle section 74. Hook 104 is biased toward contact with member 110of the closure trigger 26 and engagement with lockout pin 107 in firingtrigger 28 by a release spring 112. As the closure trigger 26 isdepressed, the hook 104 is moved top to rear, compressing the releasespring 112 that is captured between a rearward projection 114 on thehook 104 and a forward projection 116 on the release button 30. As theyoke 86 moves distally in response to proximal movement of the closuretrigger 26, an upper latch arm 118 of the release button 30 moves alongan upper surface 120 on the yoke 86 until dropping into an upwardlypresented recess 122 in a proximal, lower portion of the yoke 86. Therelease spring 112 urges the release button 30 outward, which pivots theupper latch arm 118 downwardly into engagement with the upwardlypresented recess 122, thereby locking the closure trigger 26 in a tissueclamping position, such as depicted in FIG. 8.

The latch arm 118 can be moved out of the recess 122 to release theanvil 18 by pushing the release button 30 inward. Specifically, theupper latch arm 118 pivots upward about pin 123 of the second basesection 52. The yoke 86 is then permitted to move proximally in responseto return movement of the closure trigger 26.

A firing trigger return spring 124 is located within the handle portion20 with one end attached to pin 106 of the second base section 52 andthe other end attached to a pin 126 on the firing trigger 28. The firingreturn spring 124 applies a return force to the pin 126 for biasing thefiring trigger 28 in a direction away from the pistol grip 24 of thehandle portion 20. The closure trigger 26 is also biased away frompistol grip 24 by engaging surface 128 of firing trigger 28 biasingfront surface 130 of closure trigger 26.

As the closure trigger 26 is moved toward the pistol grip 24, its frontsurface 130 engages with the engaging surface 128 on the firing trigger28 causing the firing trigger 28 to move to its “firing” position. Whenin its firing position, the firing trigger 28 is located at an angle ofapproximately 45° to the pistol grip 24. After staple firing, the spring124 causes the firing trigger 28 to return to its initial position.During the return movement of the firing trigger 28, its engagingsurface 128 pushes against the front surface 130 of the closure trigger26 causing the closure trigger 26 to return to its initial position. Astop member 132 extends from the second base section 52 to prevent theclosure trigger 26 from rotating beyond its initial position.

The surgical stapling and severing instrument 10 additionally includes areciprocating section 134, a multiplier 136 and a drive member 138. Thereciprocating section 134 comprises a wedge sled in the implementportion 22 (not shown in FIGS. 6-9) and a metal drive rod 140.

The drive member 138 includes first and second gear racks 141 and 142. Afirst notch 144 is provided on the drive member 138 intermediate thefirst and second gear racks 141, 142. During return movement of thefiring trigger 28, a tooth 146 on the firing trigger 28 engages with thefirst notch 144 for returning the drive member 138 to its initialposition after staple firing. A second notch 148 is located at aproximal end of the metal drive rod 140 for locking the metal drive rod140 to the upper latch arm 118 of the release button 30 in its unfiredposition.

The multiplier 136 comprises first and second integral pinion gears 150and 152. The first integral pinion gear 150 is engaged with a first gearrack 154 provided on the metal drive rod 140. The second integral piniongear 152 is engaged with the first gear rack 141 on the drive member138. The first integral pinion gear 150 has a first diameter and thesecond integral pinion gear 152 has a second diameter which is smallerthan the first diameter.

FIGS. 6, 8 and 9 depict respectively the handle portion 20 in the startposition (open and unfired), a clamped position (closed and unfired) anda fired position. The firing trigger 28 is provided with a gear segmentsection 156. The gear segment section 156 engages with the second gearrack 142 on the drive member 138 such that motion of the firing trigger28 causes the drive member 138 to move back and forth between a firstdrive position, shown in FIG. 8, and a second drive position, shown inFIG. 9. In order to prevent staple firing before tissue clamping hasoccurred, the upper latch arm 118 on the release button 39 is engagedwith the second notch 148 on the drive member 138 such that the metaldrive rod 140 is locked in its proximal-most position, as depicted inFIG. 6. When the upper latch arm 118 falls into the recess 122, theupper latch arm 118 disengages with the second notch 148 to permitdistal movement of the metal drive rod 140, as depicted in FIG. 9.

Because the first gear rack 141 on the drive member 138 and the gearrack 154 on the metal drive rod 140 are engaged with the multiplier 136,movement of the firing trigger 28 causes the metal drive rod 140 toreciprocate between a first reciprocating position, shown in FIG. 8, anda second reciprocating position, shown in FIG. 9. Since the diameter ofthe first pinion gear 150 is greater than the diameter of the secondpinion gear 152, the multiplier 136 moves the reciprocating section 134a greater distance than the drive member 138 is moved by the firingtrigger 28. The diameters of the first and second pinion gears 150 and152 may be changed to permit the length of the stroke of the firingtrigger 28 and the force required to move it to be varied. It will beappreciated that the handle portion 20 is illustrative and that otheractuation mechanisms may be employed. For instance, the closing andfiring motions may be generated by automated means.

One embodiment of an end effector 12 of the surgical stapling andsevering instrument 10 is depicted in further detail in FIGS. 18, 19,and 23-26. As described above, the handle portion 20 produces separateand distinct closing and firing motions that actuate the end effector12. The end effector 12 advantageously maintains the clinicalflexibility of this separate and distinct closing and firing (i.e.,stapling and severing). In addition, the end effector 12 introduces theaforementioned ability to affirmatively maintain the closed spacingduring firing after the clinician positions and clamps the tissue. Bothfeatures procedurally and structurally enhance the ability of thesurgical stapling and severing instrument 10 by ensuring adequatespacing for instances where an otherwise inadequate amount of tissue isclamped and to enhance the clamping in instances where an otherwiseexcessive amount of tissue has been clamped. FIG. 10 depicts a staplecartridge embodiment 300 of the present invention installed in the endeffector 12 with the firing bar 14 in its unfired, proximal position.The staple cartridge 300 has a cartridge body 302 that is divided by anelongated slot 310 that extends from a proximal end 304 of the cartridge300 towards a tapered outer tip 306. A plurality of staple-receivingchannels 320 a-320 f are formed within the staple cartridge body 302 andare arranged in six laterally spaced longitudinal rows 500, 502, 504,506, 508, 510, with three rows on each side of the elongated slot 310.Positioned within the staple-receiving channels 320 a-320 f are thestaples 222. See FIGS. 10 and 11.

The cartridge 300 further includes four laterally spaced longitudinalrows of staple drivers 330 a, 330 b, 370 a, and 370 b as shown in FIG.11. The “first” inside staple drivers 330 a are slidably mounted withincorresponding channels 320 b and 320 c such that each driver 330 asupports two staples 222, one in a channel 320 b and one in a channel320 c. Likewise, the “second” inside drivers 330 b are slidably mountedwithin channels 320 d and 320 e such that each driver 330 b supports twostaples 222, one in a channel 320 d and one in a channel 320 e. The“outside” drivers 370 a and 370 b are slidably mounted within thestaple-receiving channels 320 a and 320 f, respectively. Each of theoutside drivers 370 a and 370 b supports a single staple 222. Drivers370 a are referred to herein as “first” outside drivers and drivers 370b are referred to herein as “second” outside drivers.

FIG. 12 illustrates a staple 222 that may be used in connection with thevarious embodiments of the present invention. The staple 222 includes amain portion 223 and two prongs 225. The prongs 225 each have a length“P” and the main portion has a width “W”. The reader will appreciatethat a variety of different types of staples may be employed. Forexample, for a vascular staple, “P” may be approximately 0.102 inches;for a regular staple, “P” may be approximately 0.134 inches; and for athick tissue staple, “P” may be approximately 0.160 inches. For all suchstaples, “W” may be approximately 0.120 inches. Other sizes of staples222 may be employed in the manners discussed below.

The inside staple drivers 330 a located on one side of the elongatedslot 310 are referred to herein as “first” inside staple drivers and theinside staple drivers 330 b located on the other side of the elongatedslot 310 are referred to herein as “second” inside staple drivers. Aswill be discussed in further detail below, in one embodiment, the secondinside staple drivers 330 b are identical to the first inside stapledrivers 330 a, except for their orientation in their respective channelsin the cartridge body 302.

FIGS. 13-15 illustrate one embodiment of a “first” inside double driver330 a for supporting and driving staples 222. As can be seen in thoseFigures, the staple driver 330 a has a primary driver portion 340 and asecondary driver portion 350 that is connected to the first primaryportion 340 by a central base member 360. The primary driver portion 340has a primary driver base 342 that has a groove 343 therein adapted tomate with a corresponding vertically extending tongue (not shown) in thecartridge body 302 for guiding and stabilizing the driver 330 a as itmoves within its respective channel. The primary driver portion 340further has a first forward support column 344 and a first rearwardsupport column 346 protruding upward from the first driver base 342. Thefirst forward support column 344 has a first forward staple-receivinggroove 345 therein and the first rearward support column 346 has a firstrearwardly staple-receiving groove 347 therein. See FIGS. 13-15. Thefirst forward support column 344 and the first rearward support column346 are spaced from each other and collectively form a first staplecradle 348 for supporting the main portion 223 of the staple 222therein.

Similarly, the secondary driver portion 350 has a secondary driver base352 and a secondary forward support column 354 and a secondary rearwardsupport column 356 protruding out from the second driver base 352. Thesecondary forward support column 354 has a secondary forwardstaple-receiving groove 355 therein and the secondary rearward supportcolumn 356 has a secondary rearward staple-receiving groove 357 therein.The secondary forward support column 354 and the secondary rearwardsupport column 356 are spaced from each other and collectively form asecondary staple cradle 358 for supporting the main portion 223 ofanother staple 222 therein.

As can be seen in FIGS. 13 and 15, the central base member 360 has anangled rearwardly facing edge 362 adapted to be engaged by acorresponding sled cam as will be discussed in further detail below. Ascan be seen in FIGS. 13 and 14, in this embodiment, the secondaryforward support column 354 of the secondary driver portion is orientedrelative to the first rearward support column 346 such that the staple222 that is supported in the secondary staple cradle 358 islongitudinally offset from the staple 222 in the first staple cradle348. The reader will appreciate that the first inside drivers 330 a areeach installed in one orientation into a corresponding pair of channels320 b and 320 c located on one side of the elongated slot 310 in thecartridge body 302. The second inside staple drivers 330 b (located onthe opposite side of the elongated slot 310 from the first inside stapledrivers 330 a) comprise inside drivers 330 a rotated 180 degrees so thattheir respective angled surfaces 363 face towards the proximal end 304of the cartridge 300 to enable them to be installed in pairs ofcorresponding channels 320 d and 320 e. Thus, in this embodiment, onlyone inside driver configuration is employed which thereby eliminates theneed for two different inside staple driver configurations for channelson each side of the elongated slot 310.

FIGS. 16 and 17 illustrate one embodiment of a “first” outside stapledriver 370 a. As can be seen in those Figures, a first outside stapledriver 370 a has a second base 372 that has an angled rearwardly facingportion 374. Protruding upward from the second base 372 is a secondforward support column 375 that has a second forward staple-receivinggroove 376 therein. A second rearward support column 377 also protrudesupward from the second base 372 in a spaced-apart relationship withrespect to the second forward support column 375. The second rearwardsupport column 377 has a second rearward staple-receiving groove 378therein. The support columns 375, 377 collectively form a second staplecradle 379 that is configured to support a staple 222 therein asillustrated in FIGS. 16 and 17. The staple drivers 370 a also have alaterally protruding rib 371 which is received in a corresponding groove(not shown) in the cartridge body 302 for guiding and stabilizing thedriver 370 a as it moves within its respective channel.

The reader will appreciate that a first outside driver 370 a isinstalled in one orientation into a corresponding channel 320 a on oneside of the elongated slot 310. A second outside staple driver 370 b (tobe located on the opposite side of the elongated slot 310 from the firstoutside staple drivers 370 a) comprises an outside driver 370 a rotated180 degrees so that the angled surface 374′ thereon faces toward theproximal end 304 of the cartridge 300 to enable it to be installed in acorresponding channel 320 f in the cartridge body 302. Thus, in thisembodiment, only one outside staple driver configuration is employedwhich avoids the need for two different outside staple driverconfigurations for channels on each side of the elongated slot 310.

FIGS. 19 and 19A illustrate in cross-section one embodiment of a staplecartridge of the present invention mounted within one type of endeffector 12. The end effector 12 in this embodiment employs a “stepped”anvil 18 of the type illustrated in FIGS. 23-25. In other embodiments,however, the bottom surface of the anvil is planar and not stepped. Ascan be seen in FIGS. 19A, and 23-25, the anvil 18 has a central portion19 that is offset or not coplanar with the two lateral side portions 21,23. Accordingly, in this embodiment, the upper surface 306 of thecartridge 300 is provided with a recessed central portion 307 and twolateral side portions 309 that are adapted to closely mate with thecorresponding portions 19, 21, 23, respectively, of the anvil 18, whenthe anvil 18 is in the closed position. See FIG. 19A.

As can be seen in FIG. 24, in this embodiment, the under surfaces 200 ofanvil 18 are provided with a series of forming pockets 202 that may bearranged in rows that correspond to the rows of channels in thecartridge 300. That is, row 205 of pockets 202 may correspond to channelrow 500. Row 207 of pockets may correspond to channel row 502. Row 209of pockets 202 may correspond to channel row 504. Row 211 of pockets 202may correspond to channel row 506. Row 213 of pockets 202 may correspondto channel row 508. Row 215 of pockets 202 may correspond to channel row510. Each pocket 202 has at least one forming surface 203 therein thatis adapted to contact the ends of the staple prongs 225 being driventherein to thereby cause the prongs 225 to bend inwardly toward eachother. In one embodiment, each pocket 202 has two intersecting arcuateforming surfaces 203 that are oriented as shown in FIG. 14A. Eacharcuate forming surface has an apex 203′ that defines a maximum pocketdepth “Z”. However other forming pocket configurations could beemployed.

Returning to FIGS. 18 and 19, it can be seen that in one embodiment, thecartridge body 302 is mounted within the cartridge tray 224. Asillustrated in FIG. 19, the cartridge body 302 is formed with two insidelongitudinally extending slots 390 and two outside longitudinallyextending slots 392. Slots 390 and 392 extend from the proximal end 304of the cartridge to its tapered outer tip 306 (shown in FIG. 10). Thisembodiment further includes a wedge sled 400 that slidably supported onthe cartridge tray 224. One wedge sled embodiment 400 includes a pair ofinside sled cams 410, wherein one inside sled cam 410 corresponds to oneof the inside longitudinally extending slots 390 and wherein the otherinside sled cam 410 corresponds to the other inside longitudinallyextending slot 390. See FIG. 19. The wedge sled 400 further includes apair of outside sled cams 420, wherein one outside sled cam 420corresponds to one of the outside longitudinally extending slots 392 andthe other outside sled cam 420 corresponds to the other outsidelongitudinally extending slot 392 as shown in FIG. 19. When assembled,the cartridge tray 224 holds the wedge sled 400 and the drivers 330 a,330 b, 370 a, 370 b inside the cartridge body 302.

As can be seen in FIG. 18, the elongate channel 16 has a proximallyplaced attachment cavity 226 that receives a channel anchoring member228 on the distal end of the frame 34 for attaching the end effector 12to the handle portion 20. The elongate channel 16 also has an anvil camslot 230 that pivotally receives an anvil pivot 232 of the anvil 18. Theclosure sleeve 32 that encompasses the frame 34 includes a distallypresented tab 234 that engages an anvil feature 236 proximate but distalto the anvil pivot 232 on the anvil 18 to thereby effect opening andclosing of the anvil 18. The firing drive member 36 is shown as beingassembled from the firing bar 14 attached to a firing connector 238 bypins 240, which in turn is rotatingly and proximally attached to themetal drive rod 140. The firing bar 14 is guided at a distal end of theframe by a slotted guide 239 inserted therein.

FIGS. 20-23 illustrate one embodiment of the wedge sled 400 of thepresent invention. As can be seen in FIGS. 20 and 23, the wedge sled 400includes a central spacer portion 402 that extends between the insidesled cams 410. A pusher block 404 is formed on the central spacerportion 402 for engagement with the middle pin 46 of the firing bar 14.A side profile of one embodiment of an inside sled cam 410 is depictedin FIG. 21. As can be seen in that FIG., the inside sled cam 410 has abottom surface 412, and a first camming surface 414 that forms an angle“G” with the bottom surface 412 and a second camming surface 415 thatextends to a top surface 416. In one embodiment, for example, the angle“G” may be 35 degrees and the angle “G′” may be 20 degrees. The heightof the inside sled cam 410 (the distance between the bottom surface 412and the top surface 416) is represented as “first” sled cam height “H”.In one embodiment, distance “H’ is approximately 0.173 inches and thelength of the top surface 416 may vary from embodiment to embodiment. Aswill be further evident as the present Detailed Description proceeds,the first sled cam height represents the vertical distance that theinside sled cams 410 will drive the corresponding inside drivers 330 a,330 b toward the anvil 18 during operation.

The wedge sled 400 further comprises lateral spacer portions 406 thatextend between the inside sled cams 410 and the outside sled cams 420 asshown in FIGS. 20 and 23. A side profile of one embodiment of an outsidesled cam 420 is depicted in FIG. 22. In this embodiment, the outsidesled cam 420 has a bottom surface 422 and a first camming surface 424that forms an angle “I” with respect to the bottom surface 422 and asecond camming surface 425 that to a top surface 426. In one embodiment,angle “I” may be approximately 35 degrees and angle “I′” may beapproximately 20 degrees. The height of the outside sled cam 420 (thedistance between the bottom surface 412 and the top surface 416) isrepresented as the “second” sled cam height “J”. In one embodiment,distance “J’ is approximately 0.163 inches. The second sled cam heightrepresents the vertical distance that the outside sled cams 420 willdrive the corresponding outside drivers 370 a, 370 b toward the anvil 18during operation. The reader will understand that the above-reciteddimensions are illustrative of one embodiment and may vary for otherembodiments.

With particular reference to FIG. 23, a portion of the staple cartridge300 is removed to expose portions of the elongate channel 16, such asrecesses 212, 214 and to expose some components of the staple cartridge300 in their unfired position. In particular, the cartridge body 302(shown in FIG. 18) has been removed. The wedge sled 400 is shown at itsproximal, unfired position with a pusher block 404 contacting the middlepin 46 (not shown in FIG. 23) of the firing bar 14. The wedge sled 400is in longitudinal sliding contact upon the cartridge tray 224 andincludes wedges sled cams 410, 420 that force upward the double drivers330 a, 330 b and the single drivers 370 b, 370 b as the wedge sled 400moves distally. Staples 222 (not shown in FIG. 23) resting upon thedrivers 330 a, 330 b, 370 a, 370 b are thus also forced upward intocontact with the anvil forming pockets 202 in anvil 18 to form closedstaples. Also depicted is the channel slot 45 in the elongate channel 16that is aligned with the elongated slot 310 in the staple cartridge 300.

FIG. 24 depicts the end effector 12, which is in an open position by aretracted closure sleeve 32, with a staple cartridge 300 installed inthe elongate channel 16. The firing bar 14 is at its proximal position,with the upper pin 38 aligned in a non-interfering fashion with theanvil pocket 40. The anvil pocket 40 is shown as communicating with thelongitudinal anvil slot 42 in the anvil 18. The distally presentedcutting edge 48 of the firing bar 14 is aligned with and proximally fromremoved from the vertical slot 49 in the staple cartridge 300, therebyallowing removal of a spent cartridge and insertion of an unfiredcartridge, which may be “snapfit” into the elongate channel 16.Specifically, in this embodiment, extension features 316, 318 of thestaple cartridge 300 engage recesses 212, 214, respectively (shown inFIG. 23) of the elongate channel 16.

FIG. 25 depicts the end effector 12 of FIG. 23 with all of the staplecartridge 300 removed to show the middle pin 46 of the firing bar 14 aswell as portion of the elongate channel 16 removed adjacent to thechannel slot 45 to expose the firing bar cap 44. In addition, portionsof the shaft 23 are removed to expose a proximal portion of the firingbar 14. Projecting downward from the anvil 18 near the pivot is a pairof opposing tissue stops 244 which serve to prevent tissue from beingpositioned too far up into the end effector 12 during clamping.

FIG. 26 depicts the end effector 12 in a closed position with the firingbar 14 in an unfired position. The upper pin 38 is in the anvil pocket40 and is vertically aligned with the anvil slot 42 for distallongitudinal movement of the firing bar 14 during firing. The middle pin46 is positioned to push the wedge sled 400 distally so that the sledcams 410, 420 contact and lift double drivers 330 a, 330 b and thesingle drivers 370 a, 370 b, respectively, to drive them upwardly towardthe anvil 18.

As can be appreciated from reference to FIGS. 14A, 15A and 19A, in oneembodiment of the present invention, the distance between the bottom ofthe first staple-receiving grooves 345, 347 forming the first staplecradle 349 and the apex 203′ of forming surfaces 203 of thecorresponding forming pocket 202 of anvil 18, when the anvil 18 is inthe closed position and when the inside driver 330 a, 330 b is supportedon the cartridge tray 224, is referred to herein as the first stapleforming distance “A”. The distance between the bottom of the secondarystaple-receiving grooves 345, 347 forming the secondary staple cradle349 and the apex 203′ of the forming surface 203 of the correspondingforming pocket 202 in the anvil 18 when the anvil 18 is in the closedposition and the inside driver 330 a, 330 b is supported on thecartridge tray 224 is referred to herein as the secondary staple formingdistance “B”. In one embodiment, the first staple forming distance “A”and the secondary staple forming distance “B” are substantially equal toeach other. In other embodiments, those distances “A” and “B” may differfrom each other.

As illustrated in FIGS. 16A and 19A the distance between the bottom ofthe second staple-receiving grooves 376, 378 that form the second staplecradle 379 and the apex 203′ of the forming surface 203 of acorresponding forming pocket 202 in anvil 18 when the anvil 18 is in theclosed position and the outside drivers 370 a, 370 b are supported onthe cartridge channel 224, is referred to herein as a “second” stapleforming distance “C”. FIGS. 27 and 28 illustrate the forming of staplessupported on some of the first outside drivers 370 a. In FIG. 27, one ofthe outside sled cams 420 of the wedge sled 400 is initially contactingone of the outside drivers 370 a. As the wedge sled 400 continues in thedriving direction represented by arrow “K” in FIG. 28, the outside sledcam 420 causes the outside drivers 370 a drive the staples 222 supportedthereby into the staple forming pockets 202 in the anvil 18. Likewise,as the wedge sled 400 is driven in the driving direction “K”, the insidesled cams 410 contact the inside drivers 330 a, 330 b and causes them todrive the staples 222 supported thereby into the corresponding stapleforming pockets 202 in the anvil 18.

As indicated above, in some applications involving an area of variedtissue composition, it can be desirable to form rows of staples whereinthe formed (final) heights of the staples in a row that is the farthestdistance away from the cut line are greater than the formed (final)heights of those staples in the row that is closest to the cut line. Inother applications, it may be desirable for the formed heights of thestaples in a single row to increase (or decrease) from staple to staple.Another clinical benefit would be to have the formed heights of thestaples in the outermost rows larger than formed heights of the staplesin the inside rows. The various embodiments of the subject invention canprovide these results while employing identical staples in all of therows.

As the present Detailed Description proceeds, those staples 222 in theoutermost rows 520, 530 of staples (those staples formed using theoutside staple drivers 370 a, 370 b) will be referred to hereinafter asstaples 222′ and those staples in the innermost rows 522, 524, 526, 528of staples (those staples formed using the inside staple drivers 330 a,330 b) will be referred to hereinafter as staples 222″. It will beunderstood, however, that staples 222′ and 222″ are identical to eachother prior to being formed by the various embodiments of the presentinvention. That is, staples 222′ and 222″ each have identical pronglengths “P” and widths “W”. Returning to FIGS. 14A-16A and 21 and 22,the above desired effects may be attained by altering the staple formingdistances “A”, “B”, and “C” relative to each other and/or the sled camheights “H” and “J”. In one embodiment of the subject invention, forexample, the height “H” of each of the inside sled cams 410 issubstantially equal to the sled height “J” of each of the outside sledcams 420. See FIGS. 21 and 22. In this embodiment, the staple formingdistances “A” and “B” are substantially equal to each other, butdistances “A” and “B” are less than the staple forming distance “C”. Thedistance “D” between the bottoms of the first staple-receiving grooves345, 347 and the bottom surface 342′ of the primary driver base 342 issubstantially equal to the distance “E” between the bottoms of thesecondary staple-receiving grooves 356, 357 and the bottom surface 352′of the secondary driver base portion 352. See FIG. 15. Also in thisembodiment, the distance “F” between the bottoms of the secondstaple-receiving grooves 376 and 378 and the bottom surface 373 of thethird base 372 of the outside drivers 370 a, 370 b (FIG. 16) is lessthan distances “D” and “E” (FIG. 15). Because the forming distance “C”is greater than the forming distances “A” and “B”, the staples 222supported and formed by the outside drivers 370 a, 370 b are notcompressed as much as the staples supported and formed by the insidedrivers 330 a, 330 b. It will be understood that similar results may beattained on the opposite side of the elongated slot 310 and the cut line600 formed in the tissue by using the same arrangements and sizes ofinside drivers 330 b and outside drivers 370 b. In an alternativeembodiment, the same effect may be achieved by altering the depths ofthe forming pockets 202 corresponding to the drivers 330 a and 370 bsuch that forming distance “C” is greater than the forming distances “A”and “B”. That is, the depth (distance “Z” in FIG. 16A) of the formingpockets 202 corresponding to the outside drivers 370 a. 370 b may begreater than the depth (distance “Z” in FIG. 14A) of the forming pockets202 that correspond to the inside drivers 330 a, 330 b.

FIG. 29 illustrates the rows of staples formed on each side of a cutline 600 utilizing this embodiment of the present invention wherein theforming distances “A” and “B” are equal to each other and the formingdistance “C” is greater than the forming distances “A” and “B”. Forexample, if forming distance “C” is 0.020″ greater than formingdistances “A” and “B”, the formed height of the outside staples 222′(represented as dimension “L” in FIG. 30) in rows 520 and 530 would be0.020 inches is greater than the formed height of the inside staples222″ (represented as dimension “M” in FIG. 31) in rows 522, 524, 526,528.

The same result may be achieved by utilizing another embodiment of thepresent invention wherein the forming distances “A”, “B” and “C” areessentially equal. In this embodiment, however, the height of each ofthe inside sled cams 410 (distance “H” in FIG. 21) is greater than theheight of each of the outside sled cams 420 (distance “J” in FIG. 22).Thus, because the height “H” of the inside sled cams 410 is greater thanthe height “J′” of the outside sled cams 420, the inside sled cams 410will drive the corresponding inside drivers 330 a, 330 b further towardsthe anvil than the outside sled cams 420 will drive the correspondingoutside drivers 370 a, 370 b. Such driving action will cause the staplessupported by the inside drivers 330 a, 330 b to be compressed to agreater extent than those staples supported by the outside drivers 370a, 370 b. For example, if distance “H” is 0.020 inches greater thandistance “J”, the formed height of staples 222′ in lines 520, 530 wouldbe 0.020″ greater than the formed height of staples 222″ in lines 522,524, 526, 528.

When employing yet another embodiment of the present invention, theoutside rows 520, 530 of staples 222′ and the inside rows 522, 528 ofstaples 222″ may be formed with heights that are greater than the formedheights of the staples 222″ in the inside rows 524, 526. See FIG. 32.This result is achieved by making the forming distances “C” greater thanthe forming distance “A” and making forming distance “A” greater thansecondary forming distance “B”.

Another embodiment of the present invention can be used to installstaples where it is desirable for the formed heights of staples in asingle row to vary. One such arrangement is depicted in FIG. 33. As canbe seen in FIG. 33, the formed heights of the staples 222′ in theoutside rows 520, 530 increase when moving from the proximal ends 521,531 of each row 520, 530, respectively to the distal ends 523, 533 ofeach row 520, 530, respectively. This effect may be accomplished bydecreasing the forming distance “C” for each succeeding driver 370 a,370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would be sized to establish a forming distance “C” that isgreater than the forming distance “C” achieved by the adjacent driver370 a and so on to achieve a condition wherein each succeeding staple222′ (moving in the direction from the proximal end to the distal end ofthe cartridge 300) would have larger formed heights. This result couldalso be attained in the staples 222″ in rows 522, 524, 526, 528 bysimilarly altering the forming distances “A” and/or “B” attained by eachdriver 330 a, 330 b. Likewise, formed heights of the staples 222′ in theoutside rows 520, 530 could be made to decrease when moving from theproximal ends 521, 531 of each row 520, 530, respectively, to the distalends 523, 533 of each row 520, 530, respectively. This result may beattained by increasing the forming distance of each succeeding driver370 a, 370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would have a forming distance “C” that is less than theforming distance “C” of the adjacent driver 370 a and so on to achieve acondition wherein each succeeding staple 222′ (moving in the directionfrom the proximal end to the distal end of the cartridge) would havesmaller formed heights. See FIG. 34.

In use, the surgical stapling and severing instrument 10 is used asdepicted in FIGS. 1-2 and 35-41. In FIGS. 1-2, the instrument 10 is inits start position, having had an unfired, fully loaded staple cartridge300 snap-fitted into the distal end of the elongate channel 16. Bothtriggers 26, 28 are forward and the end effector 12 is open, such aswould be typical after inserting the end effector 12 through a trocar orother opening into a body cavity. The instrument 10 is then manipulatedby the clinician such that tissue 248 to be stapled and severed ispositioned between the staple cartridge 300 and the anvil 18, asdepicted in FIG. 35. With reference to FIGS. 36 and 37, the clinicianthen moves the closure trigger 26 proximally until positioned directlyadjacent to the pistol grip 24, locking the handle portion 20 into theclosed and clamped position. The retracted firing bar 14 in the endeffector 12 does not impede the selective opening and closing of the endeffector 12, but rather resides within the anvil pocket 40. With theanvil 18 closed and clamped, the E-beam firing bar 14 is aligned forfiring through the end effector 12. In particular, the upper pin 38 isaligned with the anvil slot 42 and the elongate channel 16 isaffirmatively engaged about the channel slot 45 by the middle pin 46 andthe firing bar cap 44.

With reference to FIGS. 38 and 39, after tissue clamping has occurred,the clinician moves the firing trigger 28 proximally causing the firingbar 14 to move distally into the end effector 12. In particular, themiddle pin 46 enters the staple cartridge 300 through the firing driveslot 47 to effect the firing of the staples 222 (not shown in FIGS. 38and 39) via wedge sled 400 toward the anvil 18. The lowermost pin, orfiring bar cap 44, cooperates with the middle pin 46 to slidinglyposition cutting edge 48 of the firing bar 14 to sever tissue. The twopins 44, 46 also position the upper pin 38 of the firing bar 14 withinlongitudinal anvil slot 42 of the anvil 18, affirmatively maintainingthe spacing between the anvil 18 and the elongate channel 16 throughoutits distal firing movement.

With reference to FIGS. 40 and 41, the clinician continues moving thefiring trigger 28 until brought proximal to the closure trigger 26 andpistol grip 24. Thereby, all of the ends of the staples 222 are bentover as a result of their engagement with the anvil 18. The firing barcap 44 is arrested against a firing bar stop 250 projecting toward thedistal end of the channel slot 45. The cutting edge 48 has traversedcompletely through the tissue. The process is complete by releasing thefiring trigger 28 and by then depressing the release button 30 whilesimultaneously squeezing the closure trigger 26 to open the end effector12.

In various embodiments, as outlined above, a staple cartridge caninclude a first row of staples which can be deformed to a first heightand, in addition, a second row of staples which can be deformed to asecond height, wherein the first height can be shorter than the secondheight. As a result, the staples within the first row can apply a largerclamping force to soft tissue captured therein as compared to theclamping force applied by the staples within the second row. Suchembodiments can be utilized to apply a larger clamping force along theperimeter of incised tissue, for example, in order to reduce bleedingtherefrom while providing a smaller clamping force to the tissue in anadjacent row, or rows, of staples. In various embodiments, such adjacentrows of staples can provide additional support to the soft tissuewithout unnecessarily stiffening the soft tissue or constricting theflow of blood therein.

In at least one embodiment, referring to FIG. 48, each of the stapleswithin a first, or inner, staple row can be deformed to a height withina first height range and each of the staples within a second, or middle,staple row can be deformed to a height within a second height range,wherein the first height range can be different than the second heightrange. In various embodiments, the first height range and the secondheight range can be mutually exclusive or, in at least one embodiment,there can be some overlap between the two ranges. In at least oneembodiment, the staples within the first row can be deformed to a firstaverage height and the staples within the second row can be deformed toa second average height, wherein the first average height can bedifferent than the second average height. Similar to the above, each ofthe staples within a third row of staples can be deformed to a heightwithin a third height range which is different than the first heightrange and the second height range in order to apply different clampingforces to the soft tissue.

Oftentimes, further to the above, a larger clamping force can generate alarger clamping pressure within the soft tissue captured by a staple.More particularly, in at least one embodiment, a clamping force can beproportional to the product of the pressure that it applies and the areaacross which it is applied. As a result, a staple which is deformed to ashorter staple height can create a larger clamping pressure within thesoft tissue as compared to a staple which is deformed to a larger stapleheight, assuming that the area across which the clamping forces areapplied is the same. In view of the above, a surgical staple can includetissue-contacting areas configured to increase and/or decrease theclamping pressure applied by a given clamping force.

In various embodiments, referring to FIG. 42, a staple 622 can includecrown 624 and deformable members, or legs, 630 and 634 which can extendfrom crown 624. In at least one embodiment, crown 624 can includetissue-contacting surfaces 625 which can be configured to support softtissue, for example, thereon when deformable members 630 and 634 aredeformed to capture the soft tissue within staple 622. As compared toportion 223 of staple 222 (FIG. 12), surfaces 625 can provide a largersurface area to support soft tissue and, as a result, reduce thepressure applied to the soft tissue by the deformed staple legs. Furtherto the above, in various embodiments, crowns 624 and/ortissue-contacting surfaces 625, for example, can define a width which iswider than the width of the deformable members. Referring to FIG. 48,for example, crowns 624, and/or tissue-contacting surfaces thereon, canbe defined by a width “W2” which is wider than a width “W1” defined bythe cross-section of deformable members 630, for example. In variousembodiments, the width of crowns 624 and/or surfaces 625 can be selectedsuch that a desired clamping pressure is applied to the tissue capturedwithin the staples. For example, a crown 624 or surface 625 can beselected such that it is only slightly wider than one of the deformablemembers wherein, in such embodiments, less surface area is available tosupport the tissue which can increase the clamping pressure within thetissue as compared to the surface area provided by the crowns 624 orsurfaces 625 illustrated in FIGS. 46 and 47 which are much wider thanthe deformable members. In at least one embodiment, although notillustrated, the staples within a first row can include crowns having afirst width and the staples within a second row can include crownshaving a different, or second, width such that the first row of staplescan apply a first clamping pressure to the soft tissue while the secondrow of staples can apply a different, or second, clamping pressure.

In various embodiments, deformable members 630 and 634 of staple 622,for example, can be comprised of separate deformable wires or,alternatively, deformable members 630 and 634 can comprise a singlecontiguous wire extending through at least a portion of crown 624. In atleast one embodiment, the deformable members can be comprised of one ormore metals, or any other suitable deformable material, such astitanium, for example. In any event, crown 624 can be overmolded onto,or otherwise suitably attached to, at least a portion of deformablemembers 630 and 634 in order to form tissue-contacting surfaces 625. Invarious embodiments, referring to FIG. 43, a staple cartridge caninclude an inner row of staples 622 which can be deformed to a firstheight (represented by dimension “M”), a middle row of staples 622 whichcan be deformed to a second height (represented by dimension “M′”), andan outer row of staples 622 which can be deformed to a third height(represented by dimension “L”). Similar to the above, a staple cartridgecan include various staple drivers, for example, for driving staples 622against an anvil, for example, to deform the staples to such variousheights.

In various embodiments, referring to FIG. 47, a staple cartridge 600 caninclude staple drivers 670 a and 670 b, for example, which can beconfigured to deploy staples 622 from staple cartridge 600. In at leastone embodiment, similar to the above, staple driver 670 b can include afirst, or inner, cradle 626 for supporting a first, or inner, staple 622a distance “A” from datum 603, a second, or middle, cradle 627 forsupporting a second, or middle, staple 622 a distance “B” from datum603, and a third, or outer, cradle 628 for supporting a third, or outer,staple 622 a distance “C”. Datum 603 can represent a forming surface ofan anvil against which the staples can be deformed although, in variousembodiments, an anvil can include various forming surfaces which may notlie along a single datum. In any event, referring to FIG. 48, the innerstaple 622 can be deformed to a staple height represented by dimensionM, the middle staple 622 can be deformed to a staple height representedby dimension M′, and the outer staple 622 can be deformed to a stapleheight represented by dimension L. In such embodiments, the inner staple622 can be part of a first row of staples which apply a first, orlarger, clamping force to tissue “T”, the middle staple 622 can be partof a second row of staples which apply a second, or intermediate,clamping force to tissue T, and the outer staple 622 can be part of athird row of staples which apply a third, or smaller, clamping force totissue T.

In various other embodiments, referring to FIG. 46, a staple cartridge600′ can include staple drivers 670 a′ and 670 b′ which can, similar tothe above, be configured to deploy staples 622 from staple cartridge600. In at least one embodiment, staple driver 670 b′ can include afirst, or inner, cradle 626′ for supporting a first, or inner, staple622 a distance A′ from datum 603, a second, or middle, cradle 627′ forsupporting a second, or middle, staple 622 a distance B′ from datum 603,and a third, or outer, cradle 628′ for supporting a third, or outer,staple 622 a distance C′ from datum 603, where C′ can be shorter thanB′, and where B′ can be shorter than A′. In at least one suchembodiment, the outer staple 622 can be deformed to a staple heightwhich is shorter than the staple height to which the inner and middlestaples are deformed.

In various embodiments, as illustrated in FIGS. 46 and 47, staples 622can have the same, or at least substantially the same, undeformed height“P”. In other various embodiments, as illustrated in FIGS. 44 and 45, astaple cartridge can include staples having different undeformed stapleheights. In at least one embodiment, referring to FIG. 44, staplecartridge 600″, for example, can include inner staple 622 a supported adistance A″ away from datum 603, middle staple 622 b supported adistance B″ away from datum 603, and outer staple 622 c supported adistance C″ away from datum 603, where inner staple 622 a can be tallerthan staples 622 b and 622 c when measured in their undeformedconfigurations. In various embodiments, the undeformed heights of thestaples and the distances in which the staples are displaced can becalculated to provide a suitable arrangement of deformed staple heightswithin the targeted soft tissue. Similar to the above, in at least oneembodiment and referring to FIG. 45, staple cartridge 600′″, forexample, can include inner staple 622 d supported a distance A′″ awayfrom datum 603, middle staple 622 e supported a distance B′″ away fromdatum 603, and outer staple 622 f supported a distance C′″ away fromdatum 603, where inner staple 622 d can be shorter than staples 622 eand 622 f, and where middle staple 622 e can be shorter than staple 622f when measured in their undeformed configurations.

As outlined above, a staple can be configured to apply a clamping forceand pressure to soft tissue captured therein. In various circumstances,it may be desirable to maintain such a clamping force and pressure for aprolonged period of time. In other circumstances, it may be desirablefor the clamping force and/or pressure to increase and/or decreaseduring the healing process. In various embodiments, various portions ofa staple, such as the crown and/or deformable members, for example, canbe coated in a material which can expand and increase the clamping forceand/or pressure to the soft tissue after the staple has been deployedinto the tissue. In at least one embodiment, various portions of astaple can be comprised of a dissolvable, bioabsorbable, orbiofragmentable material which, as the material breaks down, can slowlyrelieve the clamping force and/or pressure applied to the soft tissue.Such embodiments are described in greater detail below.

In various embodiments, referring to FIG. 49, a surgical staple 722 caninclude a first deformable member 730 including first leg 731 and secondleg 732 and, in addition, a second deformable member 734 including firstleg 735 and second leg 736. In at least one embodiment, staple 722 canfurther include dissolvable crown 724 which can be configured to holddeformable members 730 and 734 relative to each other and, after crown724 has been dissolved, permit deformable members 730 and 734 to moverelative to each other. Similar to the above, referring to FIGS. 50 and51, a surgical staple 722′ can include a first deformable member 730′, asecond deformable member 734′, and a crown 724′ which can connect thedeformable members before it is dissolved. In various embodiments, eachdeformable member can include a base 723′ which can connect the firstand second legs of the deformable member where, in at least oneembodiment, the bases 723′ of the deformable members can be embedded ina material which is overmolded thereon. In various embodiments, asoutlined above, the material can include a dissolvable, bioabsorbable,or biofragmentable material such as Vicryl and/or PDS from Ethicon,Inc., for example. As used herein, the terms dissolvable, bioabsorbable,and biofragmentable all generally refer to materials that can be atleast partially assimilated by the body after being implanted into apatient, for example.

In use, staple 722′, for example, can be inserted into soft tissue via astapler and can be deformed into the configuration illustrated in FIG.52. More particularly, in at least the illustrated embodiment,deformable members 730′ and 734′ can be deformed by the anvil of thestapler such that ends 733′ of legs 731′ and 735′ are brought into closeproximity to crown 724′, for example. Once staple 722′ is implanted intothe tissue, crown 724′ may begin to break down, dissolve, and weaken.More particularly, referring to FIG. 53, the bioabsorbable material ofcrown 724′ may deteriorate to the point where first member 730′ andsecond deformable member 734′ become disconnected from each other. Oncefirst member 730′ and second member 734′ have become disconnected, theycan move relative to one another as illustrated in FIG. 54. The timerequired for crown 724′ to sufficiently dissolve may depend on thematerial used and/or the size of crown 724′. Polyglatin 910 material,sold under the tradename Vicryl, for example, may dissolve in 7-14 days.

In various embodiments, a dissolvable crown may provide severaltherapeutic advantages. For example, when staple 722′ is initiallydeployed, deformable members 730′ and 734′ may significantly compressthe tissue within the staple against crown 724′. In some applications,this compression may be desirable to limit bleeding from the tissue. Ascrown 724′ deteriorates, the gap between the deformed members 730′ and734′ and crown 724′ may increase thereby relaxing the compressive forcesacting on the tissue. In some applications, relaxing the compressionforces during the healing process may allow the tissue to slowly expandand return to its normal thickness over a period of time. In someembodiments, crown 724′ can be coated with a hydrophilic material thatinitially expands to compress the tissue captured within the staplebefore dissolving away thereafter. In these embodiments, the hydrophilicmaterial can expand by absorbing water from the surrounding tissue andfluids. In addition to the above, staple 722′, when it is inserted intothe tissue, may be very stiff and, if several staples are inserted intothe tissue, the tissue may not be permitted to move and expand duringthe healing process. However, after crowns 724′ of staples 722′ havedissolved, the deformable members of the staples may be able to moverelative to each other while still holding the underlying tissuetogether.

In various embodiments, the deformable members of a staple may becomprised of a substantially non-dissolvable or non-bioabsorbablematerial. In other embodiments, at least one of the deformable membersmay be comprised of a dissolvable, bioabsorbable, or biofragmentablematerial such as magnesium or iron, for example. In at least oneembodiment, the iron is pure iron. In either event, the dissolvablematerial of the deformable members 730′ and 734′, for example, can beselected such that they dissolve at the same rate as, slower than, orfaster than the dissolvable material of crown 724′, for example. In atleast one example, the material of crown 724′ can be selected such thatit completely dissolves away while deformable members 730′ and 734′ arestill holding tissue together. In other various embodiments, thematerial of first deformable member 730′ can be selected such that itdissolves faster than the material of second deformable member 734′.Accordingly, the deformable members of these embodiments may allow for astaggered release of the tissue. In other various embodiments, at leasttwo adjacent staples can be connected by a bridge before and/or afterthe staples have been deployed into the tissue. In these embodiments,the bridge connecting the staples can be comprised of materials thatdissolve away at the same rate, and/or a different rate, than the firstand second staples. In these embodiments, the bridges can dissolve awaybefore the first staples and/or the second staples allowing for astaggered release of the tissue.

In various embodiments, the staples described above can be used toapproximate tissue, i.e., the staples can secure resected or damagedtissue such that the strength of the resected or damaged tissueapproximates that of healthy tissue. To this end, a method ofapproximating tissue can include suturing tissue with a surgical staplecomprised of a dissolvable material and a non-dissolvable material toapproximate tissue in a first state, and dissolving the dissolvablematerial to cause the remaining non-dissolvable material to approximatethe tissue in a second state. In at least one embodiment, the tissueapproximation in the second state is more flexible than in the firststate.

In addition to the above, a crown may be comprised of at least twoovermolded or co-molded materials. More particularly, referring to FIG.55, crown 724″ of staple 722″ may be comprised of a first material 740″overmolded onto at least a portion of deformable members 730″ and 734″and a second material 742″ overmolded onto first material 740″, forexample. In such an embodiment, second material 742″ can be configuredto dissolve away quickly thereby allowing deformable members 730″ and734″ to separate from each other early on in the healing process.However, in at least one embodiment, first material 740″ can be selectedto dissolve at a slower rate than second material 742″ in order forcrown 724″ to continue to provide a compressive force on the tissue evenafter second material 742″ has completely dissolved away. In at leastone embodiment, first material 740″ can be injection molded ontodeformable members 730″ and 734″ and then permitted to cure, and/orsubstantially solidify, before second material 742″ is injection moldedonto first material 740″. In other various embodiments, first material740″ and second material 742″ can be injection molded onto deformablemembers 730″ and 734″ at substantially the same time or in rapidsuccession. In these embodiments, the first and second materials canchemically bond together to provide sufficient strength therebetween sothat the staple may be handled without the first and second materialsseparating from one another. In other embodiments, the first and secondmaterials can form mechanically interlocking features to accomplish thesame result.

In at least one embodiment, referring to the embodiment illustrated inFIG. 51, crown 724′ may include reduced cross-section 737′ intermediateportions 738′ and 739′. In use, intermediate section 737′, as it has asmaller cross-section than portions 738′ and 739′, may completelydissolve away before sections 738′ and 739′ thereby allowing firstmember 730′ to become unconnected from second member 734′ before theentirety of crown 724′ has dissolved. In at least one embodiment, thecross-sections of sections 737′, 738′, and 739′ can be selected suchthat deformable members 730′ and 734′ can become unconnected at adesired stage in the healing process. In at least one embodiment,referring to FIG. 56A, crown 734′″ of staple 722′″ can include scoremarks 743′″ which reduce the thickness of crown 724′″ in the scoredareas. In these embodiments, the score marks may be formed when crowns724′″ are overmolded onto deformable members 730′″ and 734′″ or formedby a cutting tool thereafter. As a result of score marks 743′″, crown724′″, as it dissolves, can break up into several small pieces whichare, in some circumstances, more easily absorbable by the body. In atleast one embodiment, referring to FIG. 56B, crown 724“ ” may include aplurality of pockets 744″″ intermediate raised portions 745″″. In use,the material intermediate raised portions 745″ may dissolve away leavingbehind a lattice, or grid, of raised portions 745″″ intermediatedeformable members 730″ and 734″″.

In at least one embodiment, a crown of a surgical staple can alsocomprised of at least one therapeutic drug. In these embodiments, as thedissolvable material deteriorates, the therapeutic drug can be absorbedby the surrounding tissue. In some embodiments, the drug is dispersedthroughout the dissolvable material such that the drug is steadilyreleased during the healing process. In other embodiments, however, thetherapeutic drug may be unevenly dispersed throughout the dissolvablematerial, or layered within and/or on the material, to provide anincreased dosage of the drug at a particular stage in the healingprocess.

In various embodiments, a crown overmolded or assembled onto variousportions of a staple may act as an electrical insulator. In at least oneembodiment, a staple having such a crown or insulator may reduce thepossibility of arcing along a row of staples when an electrocauterydevice is used in situ, for example. In effect, the absorbableinsulators, or crowns, on the staples can substantially prevent anelectrical current from jumping between staples as the top of eachstaple may not be electrically conductive under normal operatingconditions. As a result, the possibility of damaging tissue may bereduced.

In various circumstances, when one or more of the deformable members ofa staple are inserted through soft tissue, for example, the deformablemembers can puncture the soft tissue creating holes therein. As aresult, eventhough the deformable members can substantially fill thepuncture holes, blood may flow, at least initially, from the soft tissuesurrounding the puncture holes. In various embodiments of the presentinvention, as indicated above, at least a portion of the deformablemembers can expand and apply a compressive force against the soft tissuein order to stop, or at least reduce, bleeding from the soft tissuesurrounding the puncture holes. In at least one embodiment, referring toFIGS. 81-87, at least a portion of first and second deformable members1130 and 1134 can be coated with expandable coating 1199. In variousembodiments, referring to FIG. 82, expandable coating 1199 can have afirst diameter when it is initially inserted into the soft tissue andcan apply, depending upon the size of the deformable members and thepuncture holes, a first compressive force to the soft tissue surroundingthe deformable members. Thereafter, referring to FIG. 86, expandablecoating 1199 can increase in size to apply a larger, or second,compressive force to the soft tissue surrounding the deformable members.In various embodiments, this second compressive force may be sufficientto close, or at least constrict, the blood vessels in the soft tissuesurrounding the puncture hole to eliminate, or at least reduce, the flowof blood therethrough.

In various embodiments, expandable coating 1199 can be comprised of ahydrophilic material, or any other suitable material which has anaffinity for water, that can absorb blood, or other fluids in thesurgical site, in order to expand as described above. In at least oneembodiment, a fluid can be introduced into the surgical site which cancause expandable coating 1199 to expand. In various embodiments,expandable coating 1199 can be comprised of a cross-linked estercompound having a polyethylene glycol base polymer, for example. In atleast one such embodiment, expandable coating 1199 can be overmoldedonto at least a portion of staple 1122 using an injection moldingprocess. In various embodiments, the deformable members and/or crown,such as crown 1124, for example, can be entirely, or at least partially,comprised of an expandable material. In at least one such embodiment,the deformable members and/or crown can expand to compress the tissuecaptured within the deformable members after they have been deformed. Ineither event, after expandable material 1199 has expanded, at least aportion thereof can begin to dissolve and can be absorbed by thepatient's body. In such embodiments, the second compressive forceapplied to the soft tissue can be relaxed and the soft tissue can bepermitted to expand and grow in order to fill the puncture holes, forexample. Such embodiments can be particularly useful when the deformablemembers and/or crown are also comprised of dissolvable or bioabsorbablematerials as described above. In various embodiments, the expandablecoating can also comprise a therapeutic agent, for example, which can bereleased as expandable coating 1199 is dissolved, for example. Furtherembodiments are disclosed in U.S. patent application Ser. No.11/824,446, entitled SURGICAL STAPLE HAVING AN EXPANDABLE PORTION, whichwas filed on Jun. 29, 2007, now U.S. Patent Application Publication No.2009/0001121, the entire disclosure of which is hereby incorporated byreference herein.

In various embodiments, referring to FIGS. 88-91, surgical staple 1222can include crown 1224, first deformable member 1230, and seconddeformable member 1234 where deformable members 1230 and 1234 can extendfrom crown 1224. In at least one embodiment, at least a portion of firstdeformable member 1230 and/or second deformable member 1234 can have anon-circular cross-section. More particularly, referring to FIG. 88, thecross-section of deformable member 1234, for example, can includearcuate portion 1295 and flat portion 1297. In various embodiments,deformable members 1230 and/or 1234 can comprise a wire having across-section which is substantially constant throughout the length ofthe wire or, in other embodiments, a wire having more than onecross-section. In at least one embodiment, although not illustrated, afirst deformable member and a second deformable member can havedifferent cross-sections. In at least one such embodiment, the firstdeformable member can include a substantially circular cross-section,for example, and the second deformable member can include a non-circularcross-section, for example. In other various embodiments, the firstdeformable member can include a non-circular cross-section which isdifferent than a non-circular cross-section of the second deformablemember.

In various embodiments, the cross-sectional geometry of deformablemembers 1230 and 1234, for example, can control the manner and directionin which deformable members 1230 and 1234 are bent when they aredeformed by an anvil as described above. In at least one embodiment,flat portions 1297 can be oriented such that they are facing each otherand, as a result, flat portions 1297 can cause deformable members 1230and 1234 to bend toward each other when a force is applied thereto. Inother various embodiments, flat portions 1297, for example, can beoriented in any suitable manner to allow the deformable members to bendin a desired direction. In effect, the size and location of flat portion1297 can affect the moment of inertia of the cross-section of thedeformable members and, correspondingly, affect the manner in which thedeformable members respond to the bending stress applied thereto. In atleast one embodiment, the deformation of the deformable members can becontrolled in order to apply a desired compressive force to the softtissue captured within the staple. More particularly, in at least oneembodiment, deformable members 1230 and 1234 can be bent until theycontact the soft tissue and apply a compressive force to the soft tissuewhere the amount of force applied is largely determined by the amountand direction in which deformable members 1230 and 1234 are deformedand, in addition, the geometry of the portion of the deformable memberswhich is in contact with the soft tissue. For example, a flat portion ofa deformable member can be configured to apply a lower clamping pressureto soft tissue than a round portion as a flat portion may provide morecontact area across which the clamping force can be applied. In furthervarious embodiments, the cross-sections of deformable members caninclude any suitable combination of flat, arcuate, and/or radiusedsurfaces including those disclosed in U.S. patent application Ser. No.11/824,299, entitled SURGICAL STAPLE HAVING A DEFORMABLE MEMBER WITH ANON-CIRCULAR CROSS-SECTIONAL GEOMETRY, which was filed on Jun. 29, 2007,now U.S. Patent Application Publication No. 2008/0082125, the entiredisclosure of which is hereby incorporated by reference herein.

In various embodiments, referrring to FIGS. 57-65, staple 822 caninclude base 823, first deformable member 830, and second deformablemember 834 where, in at least one embodiment, staple 822 can furtherinclude crown 824 having apertures 846 defined therein which can beconfigured to receive the first and second deformable members. Asdescribed in further detail below, deformable members 830 and 834 can beconfigured to move, or slide, within apertures 846 such that base 823can be moved relative to crown 824. In at least one such embodiment,each aperture 846 can define an axis 847 extending therethrough wherethe deformable members can be configured to move along axes 847 whenthey are moved within apertures 846. In various embodiments, crown 824,referring to FIG. 60, can include recess 848 which can be configured toreceive base 823 and at least limit, if not prevent, relative movementbetween base 823 and crown 824. In at least one embodiment, base 823 canbe movably positioned within recess 848 such that recess 848 can permitdeformable members 830 and 834 to move along axes 847 but at leastinhibit base 823 from moving transversely to axes 847. In variousembodiments, recess 848 can be configured to receive base 823 in apress-fit and/or snap-fit configuration such that, once base 823 ispositioned in recess 848, base 823 can be substantially immovablerelative to crown 824.

In various embodiments, referring to FIGS. 66-69, staples 822 can beremovably stored within a staple cartridge, such as staple cartridge800, for example. In at least one embodiment, staple cartridge 800 caninclude body 801 having cavities 802 defined therein. Staple cartridgebody 801 can further include deck 803 having top surface 804 wherecavities 802 can include an opening in top surface 804. In variousembodiments, each cavity 802 can be configured to receive at least aportion of a staple 822 where deck 823 can include recesses 805 whichcan be configured to removably receive crowns 824. In use, referring toFIG. 66, base 823 can be situated in a first position in cavity 802before it is moved toward crown 824. In at least one embodiment,deformable members 830 and 834 can include ends 819 where, in this firstposition, ends 819 can be positioned within or proximal to apertures846. In such embodiments, as a result, when deformable members 830 and834 are moved relative to crown 824 as described above, deformablemembers 830 and 834 can be pre-aligned with axes 847 and the possibilityof deformable members 830 and 834 becoming misaligned with apertures 846can be reduced.

In various embodiments, referring to FIGS. 67 and 68, deformable members830 and 834 and base 823 of staple 822 can be moved, or slid, relativeto crown 824 by driver 850. In at least one embodiment, as outlinedabove, staple cartridge 800 can further include a wedge sled configuredto lift driver 850 and move base 823 toward crown 824. Although thewedge sled is not illustrated in FIGS. 67 and 68, exemplary sleds aredescribed and illustrated in the present application and can includewedge sled 400 in FIG. 20, for example. In various embodiments,referring to FIG. 67, driver 850 can push or slide base 823 upwardlyuntil base 823 contacts crown 824 and engages recess 848 as describedabove. Thereafter, referring to FIGS. 68 and 69, base 823 and crown 824can be forced upwardly by driver 850 such that crown 824 is removed fromrecess 805. In various embodiments, crown 824, for example, can bepress-fit or snap-fit within recesses 805 such that driver 850 mustapply a sufficient force to dislodge crown 824 from recess 805. In othervarious embodiments, as described in greater detail below, crown 824,for example, can be integrally molded with deck 803 such that driver 850must apply a sufficient force to base 823 to break crown 824 away fromstaple cartridge body 801.

In various embodiments, driver 850, for example, can be configured todrive deformable members 830 and 834 against an anvil such that thedeformable members are deformed by the anvil, as described above. As aresult, also similar to the above, the deformable members can capturethe soft tissue and compress it against crown 824. In variousembodiments, crown 824 may further include tissue-contacting surface 825which can be used to control the compressive pressure applied to thesoft tissue as outlined above. By way of example, when surface 825includes a large area against which the soft tissue is compressed, thecompressive pressure applied to the soft tissue can be much less thanwhen surface 825 includes a smaller area. In at least one embodiment,tissue-contacting surface 825 can have a first width and base 823 canhave a second width. In at least one such embodiment, the first width oftissue-contacting surface 825 can be wider than the second width of base823 such that tissue-contacting surface 825 comes into contact withtissue and not base 823.

In various embodiments, tissue can be captured and compressed betweenstaple cartridge 800 and the anvil before staples 822 are deployed intothe soft tissue. In at least one embodiment, crowns 824 can bepositioned within recesses 805 of staple cartridge body 801 such thatsurfaces 825 of crowns 824 can be aligned, or substantially flush, withtop surface 804 of deck 803. In at least one such embodiment, as aresult, the compressive force, or pressure, applied to the soft tissueby deck 803 and crowns 824 can be substantially the same. In othervarious embodiments, crowns 824 can be positioned within recesses 805such that surfaces 825 are positioned above top surface 804 of stapledeck 803. In such embodiments, the compressive force, or pressure,applied to the soft tissue by crowns 825 can be larger than thecompressive force, or pressure, applied by deck 803. In variousembodiments, the relative distance between surfaces 825 and top surface804 can be selected to provide a desired pre-deployment compressionforce, or pressure, to the soft tissue. In other various embodiments,surfaces 825 can be positioned below top surface 804 of deck 803 suchthat the compression force, or pressure, applied to the soft tissue bysurfaces 825 is less than the compressive force, or pressure, applied bydeck 803.

In various embodiments, referring to FIGS. 58, 61, and 64, staple 822′can include deformable members 830′ and 834′ which may be configured topierce crown 824′ in lieu of passing through apertures as describedabove with respect to staple 822. In such embodiments, ends 819′ of thedeformable members can be sharp enough to puncture crown 824′ and createholes therein which can allow deformable members 830′ and 834′ to move,or slide, relative thereto. In other various embodiments, referring toFIGS. 59, 62, and 65, staple 822″ can include deformable members 830″and 834″ which can be positioned outside the perimeter of crown 824″. Inat least one such embodiment, although not illustrated, crown 824″ caninclude recesses, or slots, which can be configured to slidably receivedeformable members 830″ and 834″. In any event, referring to FIGS.70-73, a staple, such as staple 822″, for example, can include aslidable crown, such as slidable crown 824″, which can be slid relativeto deformable members 830′″ and 834′″ before, during, and/or after thedeformable members are deformed by an anvil. In at least one embodiment,a staple 822′″, or any other suitable staple described herein, can bedeformed to a staple height designated by distance “L”, for example, ora shorter staple height designated by distance “M” in order to achievethe advantages discussed herein.

As outlined above, a portion of a staple cartridge can be broken awayfrom the body of the staple cartridge as a staple is deployed therefrom.In various embodiments, this portion can be configured to be positionedintermediate the base of the staple and soft tissue captured within thestaple. In at least one embodiment, referring to FIGS. 74-76, a surgicalstapling system can include staple cartridge 900 having staple pads 924integrally molded into deck 903 of staple cartridge 900. Further to theabove, staple cartridge 900 can include one or more score marks 951 andslots 952 surrounding staple pads 924 such that staple pads 924 can beeasily separated from deck 903. In at least one embodiment, referring toFIG. 76, the stapling system can include drivers 950 having shears 953which can be configured to press against staple pads 924 when bases 923of staples 922 are brought in close proximity to staple saddles 948 ofpads 924 and “punch-out” staple pads 924 from deck 903. In at least oneembodiment, after staple pads 924 have been punched out from deck 903,the staple pads can be positioned intermediate bases 923 and the tissuecaptured within staples 922. As a result, staple pads 924 can beconfigured to act as the crown of the staple or, in alternativeembodiments, act as a buttressing member intermediate the staple and thetissue. In at least one embodiment, similar to the above, staple pads924 can be comprised of a bioabsorbable material.

Similar to staple cartridges 600 and 800, for example, staple cartridge900 can be configured to deploy staples 922 such that they can bedeformed to various staple heights utilizing various staple driversand/or various staple leg lengths to provide a desired clamping forceand/or pressure as described above. In various embodiments, referring toFIGS. 77-79, other means can be utilized to provide a desired clampingforce and/or pressure to soft tissue including, in at least oneembodiment, a staple cartridge having one or more rows of staples storedtherein which have different crown heights. More particularly, in atleast one embodiment, a staple cartridge can include a first row offirst staples 1022 which have a crown height of Y, a second row ofstaples 1022′ which have a crown height of Y1, and a third row ofstaples 1022″ which have a crown height of Y2. Owing to the differentcrown heights of the staples, the third staples 1022″, for example, canbe configured to apply a larger clamping force to soft tissue capturedtherein as compared to staples 1022 and 1022′, assuming that deformablemembers 1030 and 1034 of the staples are deformed the same amount.Similarly, second staples 1022′ can be configured to apply a largerclamping force than first staples 1022.

In various embodiments, further to the above, the distance betweentissue-contacting surfaces 1025 of crown 1024 and tips 1019 of thedeformable members of first staples 1022, i.e., distance X, can belarger than the distances between the tissue-contacting surfaces 1025and deformable member tips 1019 of staples 1022′ and 1022″, i.e.,distances X1 and X2, respectively. In such embodiments, when deformablemembers 1030 and 1034 of each of the staples are deformed the samedistance, staple 1022 can define a larger area, or volume, for the softtissue to reside therein as compared to staples 1022′ and 1022″. Owingto the larger area, or volume, defined by staple 1022, deformablemembers 1030 and 1034 may apply a lesser clamping force to the softtissue as compared to staples 1022′ and 1022″ and, as a result, suchstaples can be selectively utilized to provide a desired therapeuticeffect. In at least one such embodiment, each staple 1022, 1022′, and1022″ can have the same overall undeformed stapled height represented bydistance “Z”, where the sum of the distances of X and Y, X1 and Y1, andX2 and Y2 can respectively equal, or at least substantially equal, Z. Toachieve the above, crowns 1024, 1024′, and 1024″ can be overmolded ontoat least portions of the deformable members of staples 1022, 1022′, and1022″, respectively, such the position of tissue-contacting surfaces1025 with respect to tips 1019 can be controlled through an injectionmolding process.

In various embodiments, further to the above, a staple cartridge caninclude, among other things, a first row of first staples 1022, a secondrow of staples 1022′, and a wedge sled for deploying staples 1022 and1022′ from the staple cartridge, for example. In at least oneembodiment, the staple cartridge can further include at least one stapledriver which can be configured to cooperate with the wedge sled todeploy the staples. Similar to the above, in various embodiments, eachstaple driver can include a first cradle for supporting a first staple1022 and a second cradle for supporting a second staple 1022′ whereinthe first and second cradles can be positioned relative to an anvilforming surface such that they can define the same, or nearly the same,distance therebetween. In such embodiments, owing to the different crownheights of staples 1022 and 1022′ as outlined above, staples 1022 canapply a different clamping force than staples 1022′ eventhough they aredriven the same, or at least substantially the same, staple-deformingdistance by the staple drivers. Stated another way, thetissue-contacting surfaces 1025 of staples 1022′ can be positionedcloser to the staple forming surface than the tissue-contacting surfaces1025 of staples 1022 eventhough the bottom surfaces 1055 of staples 1022and 1022′ are supported at substantially the same distance relative tothe staple-forming surface.

In various alternative embodiments, further to the above, the stapledrivers for deploying the various staples described herein can beintegrally-formed with the crowns of the staples, for example. In atleast one embodiment, such integrally-formed drivers can simplify theassembly of the staple cartridge and, in various circumstances, reducethe possibility of misalignment between the staple drivers and thestaples. In various embodiments, the integrally-formed drivers can be atleast partially comprised of a bio-absorbable material, for example,such that, when the staple drivers are deployed with the staples intothe patient, the staple drivers can dissolve during the healing process.

As described above and illustrated herein, rows of staples can bearranged in a linear, or at least substantially linear, arrangement, andcan be deployed by various surgical staplers including those disclosedin U.S. Pat. No. 5,697,543, entitled LINEAR STAPLER WITH IMPROVED FIRINGSTROKE, which issued on Dec. 16, 1997; U.S. Pat. No. 6,131,789, entitledSURGICAL STAPLER, which issued on Oct. 17, 2000; and U.S. Pat. No.7,143,923, entitled SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUTFOR AN UNCLOSED ANVIL, which issued on Dec. 5, 2006, the entiredisclosures of which are hereby incorporated by reference herein,although the present invention is not so limited. In variousembodiments, rows of staples can be arranged in arcuate, curved, and/orcurvi-linear arrangements to achieve the advantages and effects outlinedherein and can be deployed by surgical staplers including thosedisclosed in U.S. patent application Ser. No. 11/652,165, entitledSURGICAL STAPLING DEVICE WITH A CURVED END EFFECTOR, which was filed onJan. 11, 2007, now U.S. Pat. No. 8,540,128, the entire disclosure ofwhich is hereby incorporated by reference herein. In at least oneembodiment, referring to FIG. 80, for example, a staple cartridge can beconfigured to deploy concentric, or at least substantially concentric,rows of staples including a first row of staples having a first deformedheight represented by dimension “M” and, in addition, a second row ofstaples having a second deformed height represented by dimension “L”. Invarious circumstances, such rows of staples can be deployed by surgicalstaplers including those disclosed in U.S. Pat. No. 5,271,544, entitledSURGICAL ANASTOMOSIS STAPLING INSTRUMENT, which issued on Dec. 21, 1993,the entire disclosure of which is hereby incorporated by referenceherein.

Further to the above, the various staple cartridges disclosed herein canbe disposable. In at least one embodiment, an expended staple cartridge,or an at least partially expended staple cartridge, can be removed froma surgical stapler and replaced with another staple cartridge. In othervarious embodiments, the staple cartridge may not be removable and/orreplaceable during the ordinary use of the surgical instrument but, insome circumstances, may be replaceable while and/or after the surgicalstapler is reconditioned as described in greater detail below. Invarious embodiments, the staple cartridge can be part of a disposableloading unit or end-effector which can further include a staplecartridge carrier, anvil, cutting member, and/or staple driver. In atleast one such embodiment, the entire, or at least a portion of, thedisposable loading unit or end-effector can be detachably connected to asurgical instrument and can be configured to be replaced.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. Furthermore, the presentinvention has been discussed in terms of endoscopic procedures andapparatus. However, use herein of terms such as “endoscopic” should notbe construed to limit the present invention to a surgical stapling andsevering instrument for use only in conjunction with an endoscopic tube(i.e., trocar). On the contrary, it is believed that the presentinvention may find use in any procedure where access is limited to asmall incision, including but not limited to laparoscopic procedures, aswell as open procedures. Moreover, the unique and novel aspects of thevarious staple cartridge embodiments of the present invention may findutility when used in connection with other forms of stapling apparatuseswithout departing from the spirit and scope of the present invention.

What is claimed is:
 1. A stapling assembly, comprising: an anvilcomprising an asymmetric staple-forming pocket; and a staple cartridge,comprising: an annular row of staple cavities; and a plurality ofstaples removably stored in said staple cavities, wherein each saidstaple comprises: a crown, comprising: a first side; and a second sideopposite said first side; a first staple leg extending from said crown;and a second staple leg extending from said crown, wherein saidasymmetric staple-forming pocket is configured to form said staple bybiasing said first staple leg outwardly toward said first side and saidsecond staple leg outwardly toward said second side.
 2. An end effector,comprising: an anvil comprising an asymmetric staple-forming pocket; anda staple cartridge comprising: an annular row of staple cavities; and aplurality of staples removably stored in said staple cavities, whereineach said staple comprises: a crown, comprising: a first side; and asecond side opposite said first side; a first deformable memberextending from said crown; and a second deformable member extending fromsaid crown, wherein said asymmetric staple-forming pocket is configuredto deform said first deformable member outwardly toward said first sideand said second deformable member outwardly toward said second side. 3.An end effector, comprising: an anvil comprising a staple-formingpocket, wherein said staple-forming pocket comprises: a first formingcup; and a second forming cup; a staple cartridge, comprising: anannular row of staple cavities; and a staple removably stored in one ofsaid staple cavities, wherein said staple comprises: a crown,comprising: a first side; and a second side opposite said first side; afirst deformable member extending from said crown; and a seconddeformable member extending from said crown, wherein said first formingcup is configured to deform said first deformable member outwardlytoward said first side, and wherein said second forming cup isconfigured to deform said second deformable member outwardly toward saidsecond side.